To assess the temperatures within the prostate using the Wallterm System [ Time Frame: Assessed at primary treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess whether the Wallterm System delivers safe and consistent temperatures from base to apex; and determine the temperature range toward rectum, along the urethra. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

Delineate the extent and the location of necrosis [ Time Frame: Short term ] [ Designated as safety issue: No ]

The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH).

Other Names:

Wallterm™ Catheter (model 3010)

Wallterm™ Central Unit (model 3020-10)

Detailed Description:

The Wallterm System provides minimally invasive treatment of benign prostatic hyperplasia (BPH) via a high temperature, liquid filled, balloon thermotherapy. The catheter is composed of a silicone positioning balloon which anchors the catheter against the bladder neck. The multi-layer silicone treatment balloon may be adjusted to fit short (20-35mm) and long (40-55mm) prostates and is inflated (to approximately 650-700 mmHg / 20-22mm diameter) to ensure tight tissue contact and reduced blood perfusion. The handle contains the heating element and the liquid circulation mechanisms

Eligibility

Ages Eligible for Study:

50 Years and older (Adult, Senior)

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Men with BPH

Criteria

Inclusion Criteria:

Men with symptomatic BPH requiring treatment,

IPSS score > 15

Age > 50 years

Prostate size of 25 g or greater

Prostatic urethra length between 2.0 cm and 5.5 cm,

Ability to understand and consent to participate in this investigation,

Willingness and ability to participate in all required follow-up evaluations.

Exclusion Criteria:

Allergy towards Silicone,

Peak Urinary Flow > 15 mL/s,

Penile or urinary sphincter implant,

Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.)

Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.

Patients with gross haematuria. (Note: These patients may be eligible for this investigation if the results of a careful workup for cancer, including an X-ray study, cystoscopy and cytology, are found to be negative.)

Patients with a history of bladder neck contracture.

Patients who presently have urethral strictures, which prevent the passage of a 20 Fr endoscope (these patients may be treated after successful treatment of the stricture).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662350